Azithromycin Dose Pack Side Effects

Generic Name: azithromycin

Note: This page contains information about the side effects of azithromycin. Some of the dosage forms included on this document may not apply to the brand name Azithromycin Dose Pack.

Not all side effects for Azithromycin Dose Pack may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to azithromycin: oral capsule, oral powder for suspension, oral powder for suspension extended release, oral tablet

In addition to its needed effects, some unwanted effects may be caused by azithromycin (the active ingredient contained in Azithromycin Dose Pack). In the event that any of these side effects do occur, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur while taking azithromycin:

More common
  • Diarrhea
  • loose stools
Less common
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • fever
  • swelling
Rare
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • body aches or pain
  • burning while urinating
  • chest pain
  • chills
  • congestion
  • cough increased
  • cough producing mucus
  • dark urine
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness
  • drowsiness
  • dryness or soreness of the throat
  • earache
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • headache
  • indigestion
  • irregular or slow heart rate
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle aches and pains
  • nausea or vomiting
  • noisy breathing
  • passing of gas
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness or swelling in the ear
  • runny nose
  • shivering
  • shortness of breath
  • sneezing
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • stomach pain, fullness, or discomfort
  • stuffy nose
  • sweating
  • swelling of the face, ankles, hands, feet, or lower legs
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with sleeping
  • trouble with swallowing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • voice changes
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blurred vision
  • change in hearing
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased urine output
  • depression
  • diarrhea, watery and severe, which may also be bloody
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • greatly decreased frequency of urination or amount of urine
  • hives
  • hostility
  • increased thirst
  • irritability
  • lethargy
  • loss of hearing
  • lower back or side pain
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • stupor
  • unusual weight loss

Some side effects of azithromycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Acid or sour stomach
  • aggressive or angry
  • bad, unusual, or unpleasant (after) taste
  • belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • changes in the color of the tongue
  • crying
  • depersonalization
  • dry mouth
  • dysphoria
  • euphoria
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • heartburn
  • hyperventilation
  • increase in body movements
  • itching of the vagina or genital area
  • lack or loss of strength
  • mental depression
  • nervousness
  • pain during sexual intercourse
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash with flat lesions or small raised lesions on the skin
  • redness of the skin
  • restlessness
  • sensation of spinning
  • shaking
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore mouth or tongue
  • stomach upset
  • thick, white vaginal discharge with no odor or with a mild odor
  • unable to sleep
  • white patches in the mouth, tongue, or throat
Incidence not known
  • Difficulty with moving
  • fear or nervousness
  • increased sensitivity of the skin to sunlight
  • muscle pain or stiffness
  • pain in the joints
  • redness or other discoloration of the skin
  • severe sunburn
  • trouble sitting still

For Healthcare Professionals

Applies to azithromycin: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral powder for reconstitution extended release, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea, abdominal discomfort, vomiting, and diarrhea in up to 10% of patients. However, patients rarely (less than 1%) discontinued therapy due to these side effects. Dyspepsia, flatulence, mucositis, oral moniliasis, constipation, melena, and gastritis have been reported with a frequency of 1% or less. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of azithromycin (the active ingredient contained in Azithromycin Dose Pack) Anorexia, vomiting/diarrhea rarely resulting in dehydration, pancreatitis, oral candidiasis, pyloric stenosis, and rare cases of tongue discoloration have been reported during postmarketing experience.

Hypersensitivity

Reappearance of allergic symptoms may occur without further azithromycin (the active ingredient contained in Azithromycin Dose Pack) exposure when symptomatic therapy is discontinued. This phenomenon may be related to the long tissue half-life of the drug. Patients experiencing allergic symptoms may require prolonged periods of observation and symptomatic treatment.

Hypersensitivity side effects have rarely included angioedema, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Toxic pustuloderma with fever has been reported in at least one patient receiving azithromycin. There is also an isolated report of azithromycin-induced hypersensitivity syndrome. Allergic reactions (including arthralgia, edema, urticaria, and angioedema) and anaphylaxis (rarely fatal) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have rarely included arrhythmias (including ventricular tachycardia), prolongation of the QT interval, torsades de pointes, palpitations, hypotension, and chest pain in postmarketing experience. A causal relationship has not been established.

Hepatic

Hepatic side effects have infrequently included transient elevations of liver function tests (including AST and ALT) and elevated bilirubin. Hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure (some resulting in death), have been reported during postmarketing experience.

Local

Local side effects associated with intravenous administration of the drug have included pain at injection site (6.5%) and local inflammation (3.1%).

Nervous system

Nervous system side effects have included headache, somnolence, vertigo, and dizziness in approximately 1% of patients. Hearing disturbances including hearing loss, deafness, and/or tinnitus have been reported rarely. Paresthesia, convulsions, hyperactivity, nervousness, agitation, and syncope have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria. Photosensitivity and, rarely, serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported during postmarketing experience.

Other

Other side effects have included asthenia. Taste/smell perversion and/or loss (rare), fatigue, and malaise have been reported during postmarketing experience.

Renal

Renal side effects have rarely included elevations in serum creatinine and blood urea nitrogen. Interstitial nephritis and acute renal failure have been reported during postmarketing experience. Interstitial nephritis resulting in permanent renal failure has been reported in a patient receiving azithromycin (the active ingredient contained in Azithromycin Dose Pack) monotherapy.

Hematologic

Hematologic side effects have included decreased lymphocytes, increased eosinophils, leukopenia, and neutropenia. Thrombocytopenia has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included reduced bicarbonate and alterations in potassium.

Psychiatric

Psychiatric side effects have included aggressive reaction and anxiety during postmarketing experience.

Genitourinary

Genitourinary side effects have included vaginitis. Moniliasis has been reported during postmarketing experience.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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